Limited shock wave therapy vs sham treatment in men with Peyronie's disease: results of a prospective randomized controlled double-blind trial.

OBJECTIVE: To assess the role of extracorporeal shock wave therapy (SWT), in a prospective randomized controlled trial, comparing limited SWT vs sham therapy in men with Peyronie's disease. PATIENTS AND METHODS: In all, 36 men were randomized to six sessions of SWT or sham treatment. Geometrical measurements of penile length and deformity, and the abridged International Index of Erectile Function (IIEF) score and visual analogue score (VAS) were recorded and re-evaluated at 6 months. The patient and assessor were unaware of the treatment type. Standard nonparametric tests were used for the statistical analysis. RESULTS: A full set of outcome data was obtained for 16 patients in the intervention group and 20 in the sham/control group (mean age 58 and 60 years, respectively, mean duration of symptoms 15 and 33 months). There was no significant difference in the mean change between the control and intervention groups on any outcome measure. There were improvements in the mean (sd) dorsal and lateral angle, of 5.3 (11.66)° and 3.5 (17.38)° in the control group, and a deterioration of 0.9 (16.01)° and 0.9 (15.56)° in SWT group. Mean improvements in curved and straight lengths were 0.2 (0.58) and 0.1 (0.8) cm in the control and mean reductions of 0.1 (0.9) and 0.1 (1.49) cm in the SWT group. The mean changes in the IIEF and VAS scores were 0.1 (3.32) and -0.8 (1.77) for control and 0.56 (2.6) and -1.05 (1.79) for SWT group. CONCLUSION: There were no significant differences in changes of variables in Peyronie's disease treated with short-term SWT.